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Cuban Abdala Vaccine: Effectiveness in Preventing Severe Disease and Death from COVID-19 in Havana, Cuba; a Cohort Study
17 Pages Posted: 5 Apr 2022
More...Abstract
Introduction: In clinical trials, COVID-19 vaccines have proven safe and efficacious in reducing severe illness and death. However, additional evidence is needed on their real-world effectiveness. The aim of our study was to estimate effectiveness—globally and by age group—of a protein subunit vaccine (Abdala) in preventing severe illness and death from COVID-19.
Methods: We conducted a cohort study in Havana, Cuba, from July 9 through August 31, 2021. Data on patients with severe illness and deaths from confirmed cases of COVID-19 were retrieved from the Cuban Ministry of Public Health databases. All persons fully vaccinated with Abdala (three doses plus at least 14 days post-vaccination) during the study period were assigned to the vaccinated cohort; those who failed to meet this criterion were assigned to the unvaccinated cohort. Vaccine effectiveness was estimated using a Cox regression model. Cases and deaths were modeled accounting for different vaccination scenarios.
Results: The study included 1 108 876 persons: 895 475 in the vaccinated cohort and 213 401 in the unvaccinated cohort. Estimated effectiveness against severe illness was 94·4% (95% confidence interval [CI]: 93·0‒95·5) and 93·7% (95% CI: 91·3‒95·4) against death. Effectiveness was similar for all age groups. Cases and deaths reported during the study period corresponded to an effectiveness above 90%, as predicted by mathematical models.
Conclusions: The Cuban Abdala protein subunit vaccine was highly effective in preventing severe illness and death from COVID-19 under real-life conditions.
Funding: Cuban Ministry of Public Health. Genetic Engineering and Biotechnology Center
Declaration of Interest: We declare that SDS, MPF, FHB, MLF, GGN, GLP, VLMG, and MAA, are employees of the Centre for Genetic Engineering and Biotechnology, Havana Network, where Abdala vaccine active ingredient is produced and the formulation was developed. The remaining authors (PIMB, FODM, KAR, LSV, RGD, MVI, EGG, YON, IMV) have no conflict of interests.
Ethical Approval: The study protocol was approved by the Research Ethics Committee of the Pedro Kourí Tropical Medicine Institute (IPK)—CEI-IPK protocol 31-21, November 2021.
Keywords: COVID-19, SARS-CoV-2, vaccines, vaccination, immunization, cohort studies, Cuba
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